JPRN-UMIN000005449已完成3 期
Randomized study of anthracycline vs. TS-1 in patients with metastatic or recurrent breast cancer - Selection of effective chemotherapy for breast cancer-CONFIRM(SELECT BC-CONFIRM)
SELECT BC-CONFIRM executive committee0 个研究点目标入组 200 人开始时间: 2011年4月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old(—)
- 性别
- Female
入选标准
- 未提供
排除标准
- •1) HER2 (Her2/neu, Erb B2) IHC (3 +) or FISH (fluorescence in situ hybridization) (plus) for primary or metastatic lesion 2) Anaphylaxis against drugs or solvents used in protocol treatment 3) Active double cancers 4) Brain metastasis requiring treatment for increased intracranial pressure or requiring urgent irradiation 5) Extensive liver metastases or lymphatic lung metastases with dyspnea 6) Only one assessable lesion previously treated by radiotherapy 7) Retention of pleural fluid, ascitic fluid, or pericardial fluid requiring urgent treatment 8) Active infectious disease 9) Interstitial pneumonia or idiopathic interstitial pneumonia 10) HBs(+) 11) Diabetes mellitus that is poorly controlled or treated with insulin 12) Mental disease precluding participation in this study 13) Women who are pregnant, nursing infants,or plan to become pregnant
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